UMIN試験ID | UMIN000020784 |
---|---|
受付番号 | R000023991 |
科学的試験名 | 抗癌剤治療に伴う副作用とQOL・身体負担についての臨床研究(QL-GCU study) |
一般公開日(本登録希望日) | 2016/01/29 |
最終更新日 | 2022/12/05 22:13:02 |
日本語
抗癌剤治療に伴う副作用とQOL・身体負担についての臨床研究(QL-GCU study)
英語
Prospective observational study to evaluate quality of life during chemotherapy in advanced urothelial cancer patients comparing gemcitabine/cisplatin versus gemcitabine/carboplatin(QL-GCU study)
日本語
抗癌剤治療に伴う副作用とQOL・身体負担についての臨床研究(QL-GCU study)
英語
QOL comparison between gemcitabine/cisplatin versus gemcitabine/carboplatin for the first line treatment of advanced urothelial cancer(QL-GCU study)
日本語
抗癌剤治療に伴う副作用とQOL・身体負担についての臨床研究(QL-GCU study)
英語
Prospective observational study to evaluate quality of life during chemotherapy in advanced urothelial cancer patients comparing gemcitabine/cisplatin versus gemcitabine/carboplatin(QL-GCU study)
日本語
抗癌剤治療に伴う副作用とQOL・身体負担についての臨床研究(QL-GCU study)
英語
QOL comparison between gemcitabine/cisplatin versus gemcitabine/carboplatin for the first line treatment of advanced urothelial cancer(QL-GCU study)
日本/Japan |
日本語
尿路上皮癌
英語
urothelial cancer
泌尿器科学/Urology |
悪性腫瘍/Malignancy
いいえ/NO
日本語
The aim of the present prospective study was to compare the quality of life, safety and efficacy of gemcitabine/cisplatin or gemcitabine/carboplatin therapy in patients with advanced urothelial cancer.
英語
The aim of the present prospective study was to compare the quality of life, safety and efficacy of gemcitabine/cisplatin or gemcitabine/carboplatin therapy in patients with advanced urothelial cancer.
安全性・有効性/Safety,Efficacy
日本語
英語
探索的/Exploratory
日本語
Primary endpoint is the fatigue score changes between before and after 2 cycle of chemotherapy.
英語
Primary endpoint is the fatigue score changes between before and after 2 cycle of chemotherapy.
日本語
Secondary endpoints included QOL sub-score changes, tumor response (RECIST v1.1), and rates of weight loss, renal faction decline, toxicity and safety.
英語
Secondary endpoints included QOL sub-score changes, tumor response (RECIST v1.1), and rates of weight loss, renal faction decline, toxicity and safety.
観察/Observational
日本語
英語
日本語
英語
日本語
英語
日本語
英語
日本語
英語
日本語
英語
日本語
英語
日本語
英語
日本語
英語
日本語
英語
20 | 歳/years-old | 以上/<= |
90 | 歳/years-old | 以下/>= |
男女両方/Male and Female
日本語
Patients must have histologic proof of urothelial cancer.
Patients with primary tumors arising in the upper urinary tract (ureter or renal pelvis), bladder or urethra are eligible
Patients must have an evaluation in the department of urology.
ECOG performance status (PS) of 0, 1 or 2 if of recent onset and due entirely to the cancer and not due to comorbidity (especially if the compromised performance status is related to uncontrolled pain which is expected to be rapidly reversible when therapy starts)
Normal liver function (Transaminase (AST or ALT) </= 3 * the ULN, Conjugated bilirubin </= 1.5 mg/dl (or total bilirubin </= 2.5 mg/dl)
No severe chronic heart failure
Not severe renal dysfunction (eGFR < 30 ml/min/1.72m2)
Patients with other malignancies are eligible provided that the expected outcome from the second cancer is such that this will not interfere in the delivery of this therapy, or the assessment of response in the cystectomy specimen. The expected survival from the prior malignancy should reliably be > 4 years to be eligible for this study.
Patients must be >/= 20 years of age.
英語
Patients must have histologic proof of urothelial cancer.
Patients with primary tumors arising in the upper urinary tract (ureter or renal pelvis), bladder or urethra are eligible
Patients must have an evaluation in the department of urology.
ECOG performance status (PS) of 0, 1 or 2 if of recent onset and due entirely to the cancer and not due to comorbidity (especially if the compromised performance status is related to uncontrolled pain which is expected to be rapidly reversible when therapy starts)
Normal liver function (Transaminase (AST or ALT) </= 3 * the ULN, Conjugated bilirubin </= 1.5 mg/dl (or total bilirubin </= 2.5 mg/dl)
No severe chronic heart failure
Not severe renal dysfunction (eGFR < 30 ml/min/1.72m2)
Patients with other malignancies are eligible provided that the expected outcome from the second cancer is such that this will not interfere in the delivery of this therapy, or the assessment of response in the cystectomy specimen. The expected survival from the prior malignancy should reliably be > 4 years to be eligible for this study.
Patients must be >/= 20 years of age.
日本語
Patients must not have current, recent (within 3 weeks), or planned participation with other experimental medication clinical trials.
New York Heart Association (NYHA) Grade II or greater congestive heart failure.
History of myocardial infarction or unstable angina within 6 months prior to study enrollment.
History of stroke or transient ischemic attack within 6 months prior to study enrollment.
Clinically significant peripheral vascular disease (e.g., aortic aneurysm, aortic dissection).
Symptomatic peripheral vascular disease.
Evidence of bleeding diathesis or coagulopathy.
Known history of central nervous system or brain metastases.
Lactating women.
History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to therapy. Patients with Crohn's disease will be excluded.
Serious, non-healing wound, ulcer, or bone fracture.
Other malignancies with severe prognosis (overall survival expected within 1 year)
Inability to comply with study and/or follow-up procedures, or sign informed consent.
Patients who are not candidates, or are unwilling to undergo systemic chemotherapy.
Patients with fluid collections (such as ascites, or pleural effusions) are not eligible for therapy.
Know hypersensitivity to any component of gemcitabine, cisplatin, or carboplatin
英語
Patients must not have current, recent (within 3 weeks), or planned participation with other experimental medication clinical trials.
New York Heart Association (NYHA) Grade II or greater congestive heart failure.
History of myocardial infarction or unstable angina within 6 months prior to study enrollment.
History of stroke or transient ischemic attack within 6 months prior to study enrollment.
Clinically significant peripheral vascular disease (e.g., aortic aneurysm, aortic dissection).
Symptomatic peripheral vascular disease.
Evidence of bleeding diathesis or coagulopathy.
Known history of central nervous system or brain metastases.
Lactating women.
History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to therapy. Patients with Crohn's disease will be excluded.
Serious, non-healing wound, ulcer, or bone fracture.
Other malignancies with severe prognosis (overall survival expected within 1 year)
Inability to comply with study and/or follow-up procedures, or sign informed consent.
Patients who are not candidates, or are unwilling to undergo systemic chemotherapy.
Patients with fluid collections (such as ascites, or pleural effusions) are not eligible for therapy.
Know hypersensitivity to any component of gemcitabine, cisplatin, or carboplatin
200
日本語
名 | 真吾 |
ミドルネーム | |
姓 | 畠山 |
英語
名 | Shingo |
ミドルネーム | |
姓 | Hatakeyama |
日本語
弘前大学 大学院医学研究科
英語
Hirosaki University Graduate School of Medicine
日本語
泌尿器科
英語
Urology
036-8562
日本語
5 Zaifu-chou
英語
Hirosaki
0172395091
shingorilla2@gmail.com
日本語
名 | 真吾 |
ミドルネーム | |
姓 | 畠山 |
英語
名 | Itsuto |
ミドルネーム | |
姓 | Hamano |
日本語
Hirosaki University Graduate School of Medicine
英語
Hirosaki University Graduate School of Medicine
日本語
泌尿器科
英語
Urology
0368562
日本語
5 Zaifu-chou
英語
Hirosaki
0172395091
shingorilla2@gmail.com
日本語
弘前大学
英語
Hirosaki University Graduate School of Medicine
日本語
弘前大学 大学院医学研究科
日本語
日本語
英語
日本語
その他
英語
Oyokyo Kidney Research Institute
日本語
鷹揚郷腎研究所
日本語
その他/Other
日本語
JAPAN
英語
JAPAN
日本語
英語
日本語
英語
日本語
Dept. of Urology, Hirosaki University Graduate School of Medicine
英語
Dept. of Urology, Hirosaki University Graduate School of Medicine
日本語
5 Zaifu-chou
英語
Hirosaki
+81172395091
shingorilla2@gmail.com
いいえ/NO
日本語
英語
日本語
英語
2016 | 年 | 01 | 月 | 29 | 日 |
最終結果が公表されている/Published
83
日本語
QOL analyses were performed in 39 patients receiving GCis and in 44 patients receiving GCb. Appetite loss, role functioning, nausea/vomiting, physical, and fatigue deteriorated >10% from baseline in the GCis group but not in the GCb group. Constipation worsened, whereas scores for pain and emotional items improved in both groups. Objective response rates were 38.5 and 43.2% in the GCis and GCb groups, respectively.
英語
QOL analyses were performed in 39 patients receiving GCis and in 44 patients receiving GCb. Appetite loss, role functioning, nausea/vomiting, physical, and fatigue deteriorated >10% from baseline in the GCis group but not in the GCb group. Constipation worsened, whereas scores for pain and emotional items improved in both groups. Objective response rates were 38.5 and 43.2% in the GCis and GCb groups, respectively.
2022 | 年 | 12 | 月 | 05 | 日 |
日本語
英語
日本語
英語
日本語
英語
日本語
英語
日本語
英語
日本語
英語
日本語
英語
試験終了/Completed
2013 | 年 | 04 | 月 | 01 | 日 |
2021 | 年 | 04 | 月 | 30 | 日 |
2013 | 年 | 06 | 月 | 01 | 日 |
2025 | 年 | 03 | 月 | 31 | 日 |
日本語
観察研究
研究デザイン(コホート研究)
対象者の募集方法(2013年6月-2018月6月までに当施設を受診した患者で選択基準に合致した患者)
測定する項目:QLQ-C30によるQOL測定(化学療法の1コース目:Day1, 3, 8, 15,2コース目Day1, 3, 15)、副作用評価(CTCAEに準ずる)、治療効果(RECISTに準ずる)、体重減少、腎機能障害、抗腫瘍免疫(NK細胞、T細胞数)など
英語
Observational study
Design: Cohort study
Recruitment period: June 2013 to June 2018, at Hirosaki University Hospital, who met the inclusion criteria.
We compared quality of life (QOL) using QLQ-C30 questionnaire at day 1, 3, and 15 in each cycle. Primary endpoint is the QOL differences between before and after 2 courses of neoadjuvant chemotherapy. Secondary endpoints included tumor response (RECIST v1.1), rate of weight loss, renal faction decline, toxicity and safety, and changes of anti-tumor immune cells (NK cell or T cells).
2016 | 年 | 01 | 月 | 28 | 日 |
2022 | 年 | 12 | 月 | 05 | 日 |
日本語
https://center6.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000023991
英語
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023991
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